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Abstract

ABSTRACT Objectives: To validate the diagnostic performance of the iSelfie Heart Health tool compared to standard-of-care devices, focusing on accuracy, reliability, and classification capabilities. Methods: Vital sign measurements from 579 participants were analyzed using the iSelfie tool in calibrated and non-calibrated modes. Further analyses applied the Association for the Advancement of Medical Instrumentation (AAMI) standards and criteria for cuff-based blood pressure (BP) devices. Primary endpoints included mean absolute error (MAE) and cumulative error percentages for all vital parameters. Binary and multi-class classification analyses evaluated the device’s performance to categorize hypertension grades. Results: In calibrated mode, the iSelfie tool demonstrated high accuracy, with MAE of 4.42 beats per minute (BPM) for heart rate (HR), 8.94 mmHg for systolic BP (SBP), 7.50 mmHg for diastolic BP (DBP), and 1.16% for oxygen saturation (SaO2). When applying AAMI criteria, MAE was reduced to 4.35 BPM for HR, 5.29 mmHg for SBP, and 3.60 mmHg for DBP. Binary classification analysis to distinguish normotensive from hypertensive states yielded 84.4% sensitivity and 84.7% specificity in calibrated mode after applying AAMI criteria. Multi-class classification accuracy was highest for normotensive cases (Grade 0), with limited representation for higher grades. Conclusion: The iSelfie Heart Health tool demonstrated strong performance in measuring HR and SaO2, with improved BP accuracy following calibration and application of AAMI criteria, highlighting its clinical potential as a contactless, user-friendly tool for cardiovascular health monitoring and screening.

Article Type

Research Article

First Page

1445

Last Page

1456

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